Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
Lead Sponsor:
LG Chem
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
6-8 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
Eligibility Criteria
Inclusion
- Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
- The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
- Signed informed consent by subject's parents or LAR(Legally authorized representative)
Exclusion
- Previously received any pneumococcal vaccine
- Receipt of immunoglobulin or blood-derived product before the study
- Known or suspected immune disorder, or received immunosuppressive therapy
- Known major congenital malformation or serious chronic disorder
- Participation in another interventional trial
Key Trial Info
Start Date :
May 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2019
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03467984
Start Date
May 25 2018
End Date
March 27 2019
Last Update
August 22 2019
Active Locations (1)
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1
LG chem
Seoul, Gangseo-Gu, South Korea, 07795